K122908 is an FDA 510(k) clearance for the PRG BARRIER COAT. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on April 26, 2013, 217 days after receiving the submission on September 21, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K122908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2012 |
| Decision Date | April 26, 2013 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | LBH — Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |